Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo

  • NDC Code(s): 11344-311-15, 11344-311-21, 11344-311-35, 11344-311-39
  • Packager: Vi-Jon
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 25, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Pyrithione Zinc 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff

  • Warnings

    For external use only

  • When using this product

    • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • condition worsens or does not improve after regular use as directed
  • Keep  out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • shake well
    • for maximum dandruff controll, use every time you shampoo
    • wet hair, massage onto scalp, rinse, repeat if desired
    • for best results use at least twice a week or as directed by a doctor
  • Inactive ingredients

    water, sodium lauryl sulate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • Disclaimer

    This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Pyrithione Zinc Dandruff Shampoo & Conditioner Old Spice Men 2 in 1

  • Adverse Reactions

    Manufactured by: Vi-Jon, Inc.,

    St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

    Made in the USA

    with US and foreign parts.

    311.007/311AL

  • Principal Display Panel

    mountain

    falls

    *Compare to Head

    & Shoulders

    helps

    prevent

    flakes

    leaves hair

    clean and

    manageable

    conditioner

    pH

    balanced

    formula

    2 in 1

    dandruff

    shampoo

    with pyrithione zinc

    smooth spice

    23.7 FL OZ (700 mL)

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    2 IN 1 DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-311-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2005
    2NDC:11344-311-2188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2005
    3NDC:11344-311-391000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2005
    4NDC:11344-311-35700 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/23/2005
    Labeler - Vi-Jon (150931459)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-311)